18 days old

Medical Writer

Kelly Services
Miami, FL 33126
**Kelly Services** is currently seeking a **Job Title** in **City, State** to work a contract assignment **X month duration** for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.

**Primary Responsibilities includes but is not limited to:**

Plan and execute systematic, scientific literature search, review, appraisal and report process for multiple hematology and Urinalysis in vitro diagnostic IVD products. Compile and author Scientific Validity SVR and Clinical Performance Reports CPR incorporating literature findings with clinical performance data from multiple sources in support of IVDR remediation project. Provide critical thinking and analysis of conclusions drawn from clinical evidence to ensure intent of the Regulation is being met. Collaborate with cross-functional team members product management, regulatory, quality, R & D, program management to communicate and escalate status of project milestones. Support cross-functional questions regarding requirements for scientific validity, analytical and clinical performance, PEP/PER, PMS, PSUR and PMPF. Provide critical review of the clinical evidence compiled for the PER by other functional team members to meet the applicable regulatory requirements. Support on time delivery of Performance Evaluation Plans PEP , Performance Evaluation Reports PER , as needed per project timelines. Preparation of relevant information / responses for regulatory submissions and EUDAMED working with other members of the QA/RA department. Coordinate multiple projects at one time and provide regular reports to Management and other stakeholders as required. Perform additional scientific writing assignments or duties as assigned.

POSITION QUALIFICATIONS: Bachelor s degree required, Advanced degree preferred - scientific or medical focused. Minimum 5 years of clinical evaluation, medical or scientific writing experience in an academic setting or the diagnostic, medical device or pharmaceutical industry. Experienced in the use of scientific/clinical research methodology and databases. Knowledgeable of global regulations on clinical evidence required under IVDR or MDR. Ability to work in a fast-paced environment with effective use of prioritization, organization and time management skills. Excellent communication and interpersonal skills with the ability to communicate clearly and concisely in English. Proven problem-solving skills. Excellent technical writing skills.


**For immediate consideration, please send your resume in a WORD document to**

**Why Kelly** **** **?**

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**About Kelly** ****

At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Posted: 2020-08-31 Expires: 2020-10-01

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Medical Writer

Kelly Services
Miami, FL 33126

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